Covid 19 Vaccination in Pregnancy

Budi Wiweko

Perkumpulan Obstetri Ginekologi Indonesia

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Recent reports, however, are more consistent with initial expectations. A systematic multi-
national review of 60 studies on SARSCoV - 2 in pregnancy reported that severe illness occurred
in up to 18% of pregnant patients and critical disease complicated up to 5% of cases, comparable
to rates in the general population

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 Penyebab Kematian Ibu Januari – Juni 2021
Penyebab Kematian Ibu
Kode Wilayah Jumlah Kematian Ibu
Perdarahan Hipertensi Infeksi Abortus Gangguan Darah Gangguan Metabolik Jantung COVID-19 Lain2
11 ACEH 80 30 7 1 1 2 0 3 6 30
12 SUMATERA UTARA 110 25 21 4 0 1 3 5 9 42
13 SUMATERA BARAT 95 28 14 2 0 0 3 4 10 34
14 RIAU 8 2 0 0 0 1 0 0 5 0
15 JAMBI 17 3 9 0 0 1 0 1 0 3
16 SUMATERA SELATAN 28 6 16 1 0 0 0 0 0 5
17 BENGKULU 14 3 5 0 0 0 0 0 2 4
18 LAMPUNG 49 12 12 2 0 1 0 3 4 15
19 KEPULAUAN BANGKA BELITUNG 12 2 5 0 0 0 0 1 1 3
21 KEPULAUAN RIAU 18 5 4 0 1 0 0 0 0 8
31 DKI JAKARTA 76 19 12 0 0 3 7 2 15 18
32 JAWA BARAT 536 114 111 19 3 4 9 44 168 64
33 JAWA TENGAH 106 21 18 1 0 0 0 3 43 20
34 DI YOGYAKARTA 26 5 5 1 0 0 0 3 4 8
35 JAWA TIMUR 339 47 55 18 0 1 3 19 130 66
36 BANTEN 101 19 13 4 0 2 1 11 10 41
51 BALI 35 5 1 0 0 0 0 4 15 10
52 NUSA TENGGARA BARAT 80 25 19 7 0 0 0 5 11 13
53 NUSA TENGGARA TIMUR 152 42 16 14 0 1 11 8 0 60
61 KALIMANTAN BARAT 65 17 19 3 0 1 0 4 9 12
62 KALIMANTAN TENGAH 39 18 9 1 0 0 0 0 3 8
63 KALIMANTAN SELATAN 67 13 19 1 0 2 6 3 13 10
64 KALIMANTAN TIMUR 37 3 15 0 0 1 0 9 1 8
65 KALIMANTAN UTARA 10 0 2 0 0 0 0 0 5 3
71 SULAWESI UTARA 9 2 0 1 0 0 0 3 0 3
72 SULAWESI TENGAH 54 15 10 5 1 1 0 1 4 17
73 SULAWESI SELATAN 75 23 20 1 0 0 0 1 4 26
74 SULAWESI TENGGARA 37 4 11 1 0 0 3 0 2 16
75 GORONTALO 13 2 1 1 0 0 2 0 0 7
76 SULAWESI BARAT 29 13 3 2 0 0 0 1 1 9
81 MALUKU 18 8 3 0 0 0 0 1 0 6
82 MALUKU UTARA 2 1 0 0 0 0 0 0 0 1
91 PAPUA BARAT 19 14 2 2 0 0 0 0 0 1
94 PAPUA 17 4 3 2 0 0 1 0 4 3
TOTAL 2373 550 460 94 6 22 49 139 479 574

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 Research agenda

Ensure that pregnant women are afforded the

same autonomy as other adults to participate
in clinical trials of vaccines and therapies for
emerging pathogens

1. Vaccination in pregnancy for the primary prevention of communicable diseases has proved one of the most effective public health
interventions in recent decades, leading to significant reductions in maternal and perinatal morbidity and mortality

2. The influenza pandemics of history have highlighted the value of international surveillance systems for critical illness in pregnant women,
the importance of including pregnant women in clinical trials of vaccine efficacy and the imperative for community engagement to optimize
vaccine uptake

3. The rubella epidemics of the 1960s have highlighted the need for birth defect surveillance systems to identify teratogenic links with viral
pathogens, and the importance of understanding disease epidemiology to optimize vaccination uptake and efficacy

4. The benefits of passive immunity for tetanus and pertussis have resulted in significant reduction in infant mortality and morbidity due to
optimal timing and dosing during pregnancy

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To enable the inclusion of pregnant and lactating women in the development of COVID-19
vaccines, three key questions need to be answered:

1. What is the short term and long-term burden of COVID-19 in pregnant women, the foetus,
and infants (in all populations and ethnic groups);
2. Do pregnant women wish to be vaccinated against COVID-19 and participate in such trials;
3. Which of the candidate COVID-19 vaccines are suitable for pregnant women and should be
the focus of early clinical trials

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Pregnant persons were excluded from the initial phase 3 clinical trials of COVID-19 vaccines,
limited data are available on their efficacy and safety during pregnancy.

After developmental and reproductive toxicology studies are completed, some companies are
expected to conduct clinical trials in pregnant persons. Until then, pregnant persons and their
obstetricians will need to use available data to weigh the benefits and risks of COVID-19 vaccines.

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 Considerations for Counselling Pregnant Persons Regarding Coronavirus Disease
2019 (COVID-19) Vaccination

1. Data from animal studies (once developmental and reproductive toxicology studies become
available)
2. Lack of data on pregnancies during vaccine clinical trials
3. Risks of vaccine reactogenicity, including fever; treatment with antipyretic medications (eg,
acetaminophen) might reduce this risk
4. Timing of planned vaccination during pregnancy
5. Extensive evidence for safety of other vaccines during pregnancy
6. Risk of COVID-19 complications due to pregnancy (increased risk to pregnant person of severe
disease and death)
7. Risk of COVID-19 complications due to underlying conditions (eg, diabetes, obesity, heart
disease)
8. Risk of COVID-19 to foetus or new-born (intrauterine transmission is rare, but preterm birth
appears to be increased)
9. Risk of exposure to SARS-CoV-2 and potential for mitigation with working

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• Most states in the United States (36 of 51; 71%) encompassing 71% of the population in the
United States do not include pregnant individuals among their priority populations.
• Only 6 of 13 states that mentioned pregnancy as a priority indication for COVID-19 vaccination
and none of the 36 states not including pregnancy in priority groups linked back to the Centers for
Disease Control and Prevention definition of pregnancy as an increased risk of severe illness.

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METHODS
From December 14, 2020, to February 28, 2021, we used data from the “v-safe after vaccination
health checker” surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse
Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in
pregnant persons.

• Monitoring Systems and Covered Populations

V-safe Surveillance System and Pregnancy Registry
• V-safe is a new CDC smartphone-based active- surveillance system developed for the
Covid-19 vaccination program; enrollment is voluntary

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Outcomes
• V-safe outcomes included participant-reported local and systemic reactogenicity to the
BNT162b2 (Pfizer–BioNTech) vaccine and the mRNA-1273 (Moderna) vaccine on the day after
vaccination among all pregnant persons 16 to 54 years of age and among nonpregnant
women 16 to 54 years of age as a comparator.

• For analysis of pregnancy outcomes in the v-safe pregnancy registry, data were restricted to
completed pregnancies (i.e., live-born infant, spontaneous abortion, induced abortion, or
stillbirth).
• Participant-reported pregnancy outcomes included pregnancy loss (spontaneous abortion
and stillbirth) and neonatal outcomes (preterm birth, congenital anomalies, small size for
gestational age, and neonatal death

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1. Early data from the v-safe surveillance system, the v-safe pregnancy registry, and
the VAERS do not indicate any obvious safety signals with respect to pregnancy or
neonatal outcomes associated with Covid-19 vaccination in the third trimester of
pregnancy.
2. Continued monitoring is needed to further assess maternal, pregnancy, neonatal,
and childhood outcomes associated with maternal Covid-19 vaccination, including
in earlier stages of pregnancy and during the preconception period.
3. Meanwhile, the present data can help inform decision making about vaccination by
pregnant persons and their health

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TERIMA KASIH

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